A Validated RP-HPLC Method for the Assay of Balofloxacin in Bulk and Pharmaceutical Dosage Forms

Author(s): P. Ravisankar, Ch. Devadasu, G. Devala Rao, P. Srinivasa Babu, G. Sudhakar Saibabu and P. Venkateswar Reddy

A simple, accurate, precise, specific isocratic reversed phase-high performance liquid chromatography (RP-HPLC) method has been developed for the quantitative estimation of balofloxacin pharmaceutical formulations. RP-HPLC method was developed by using Welchrom C18 Column (4.6 x 250 mm, 5 μm), Shimadzu LC-20AT prominence liquid chromatograph. The mobile phase used is phosphate buffer (pH-3.2): acetonitrile (60 : 40% v/v) with a flow rate of 1 mL/min. The responses are measured at 295 nm using Shimadzu SPD-20A prominence UV-Vis detector. The retention times of balofloxacin found to be 5.713 min. The method posses linearity in the range of 2-10 μg/mL and correlation coefficient is 0.9999. The accuracy and reliability of the proposed method was ascertained by evaluating various validation parameters like linearity, precision and specificity according to ICH guidelines. The proposed method provides an accurate and precise quality control tool for routine analysis of balofloxacin in tablet dosage forms.

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